BCPS EXAM QUESTIONS 2025 |
GUARANTEED ACCURATE
ANSWERS |VERIFIED
Drug Importation Act of 1848 - ACCURATE ANSWERS✔✔ Prohibited
importation of unsafe/adulterated drugs
Pure Food and Drug Act of 1906 - ACCURATE ANSWERS✔✔
Identified USP/NF as official drug standard; prohibited commerce of
adulterated/misbranded drugs
Food, Drug, and Cosmetic Act of 1938 - ACCURATE ANSWERS✔✔
Required evidence of safety to the FDA before marketing; advertising
under Federal Trade Commission
Durham-Humphrey Amendment, 1951 - ACCURATE ANSWERS✔✔
Amended the FD&C Act to differentiate prescription and
nonprescription drugs
Kefauver-Harris Amendments, 1962 - ACCURATE ANSWERS✔✔
Required evidence of efficacy as well as safety; authorized FDA to
regulate advertising and establish GMP
, The Comprehensive Drug Abuse Prevention and Control Act, 1970 -
ACCURATE ANSWERS✔✔ Controlled Substance Act regulated and
scheduled controlled substances
The Orphan Drug Act, 1983 - ACCURATE ANSWERS✔✔ Assistance
and incentives for drugs targeting a patient population of less than
200,000.
Drug Price Competition and Patent Term Restoration Act, 1984 (Hatch-
Waxman) - ACCURATE ANSWERS✔✔ Expedites the availability of
generic drugs
The Food and Drug Administration Act, 1988 - ACCURATE
ANSWERS✔✔ Established FDA in DHHS
Prescription Drug User Fee Act (PDUFA), 1992 - ACCURATE
ANSWERS✔✔ Requires drug, biologics, and medical device
manufacturers to pay fees for product applications, supplements, and
other services; sunsets every 5 years.
The Dietary Supplement Health and Education Act, 1994 - ACCURATE
ANSWERS✔✔ Regulation of nutritional supplements and vitamins
FDA Modernization Act, 1997 - ACCURATE ANSWERS✔✔
Streamline clinical research; exclusivity provision for pediatric drugs;
creating of ClinicalTrials.gov
GUARANTEED ACCURATE
ANSWERS |VERIFIED
Drug Importation Act of 1848 - ACCURATE ANSWERS✔✔ Prohibited
importation of unsafe/adulterated drugs
Pure Food and Drug Act of 1906 - ACCURATE ANSWERS✔✔
Identified USP/NF as official drug standard; prohibited commerce of
adulterated/misbranded drugs
Food, Drug, and Cosmetic Act of 1938 - ACCURATE ANSWERS✔✔
Required evidence of safety to the FDA before marketing; advertising
under Federal Trade Commission
Durham-Humphrey Amendment, 1951 - ACCURATE ANSWERS✔✔
Amended the FD&C Act to differentiate prescription and
nonprescription drugs
Kefauver-Harris Amendments, 1962 - ACCURATE ANSWERS✔✔
Required evidence of efficacy as well as safety; authorized FDA to
regulate advertising and establish GMP
, The Comprehensive Drug Abuse Prevention and Control Act, 1970 -
ACCURATE ANSWERS✔✔ Controlled Substance Act regulated and
scheduled controlled substances
The Orphan Drug Act, 1983 - ACCURATE ANSWERS✔✔ Assistance
and incentives for drugs targeting a patient population of less than
200,000.
Drug Price Competition and Patent Term Restoration Act, 1984 (Hatch-
Waxman) - ACCURATE ANSWERS✔✔ Expedites the availability of
generic drugs
The Food and Drug Administration Act, 1988 - ACCURATE
ANSWERS✔✔ Established FDA in DHHS
Prescription Drug User Fee Act (PDUFA), 1992 - ACCURATE
ANSWERS✔✔ Requires drug, biologics, and medical device
manufacturers to pay fees for product applications, supplements, and
other services; sunsets every 5 years.
The Dietary Supplement Health and Education Act, 1994 - ACCURATE
ANSWERS✔✔ Regulation of nutritional supplements and vitamins
FDA Modernization Act, 1997 - ACCURATE ANSWERS✔✔
Streamline clinical research; exclusivity provision for pediatric drugs;
creating of ClinicalTrials.gov
